Misoprostol (Page 3 of 3)
Pediatric use
Safety and effectiveness of misoprostol in pediatric patients have not been established.
ADVERSE REACTIONS
The following have been reported as adverse events in subjects receiving misoprostol:
Gastrointestinal
In subjects receiving misoprostol 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14–40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13–20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo.
Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of misoprostol (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if misoprostol is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of misoprostol with magnesium-containing antacids.
Gynecological
Women who received misoprostol during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to misoprostol administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (See boxed WARNINGS.)
Elderly
There were no significant differences in the safety profile of misoprostol in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients.
Additional adverse events which were reported are categorized as follows:
Incidence greater than 1%
In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving misoprostol and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for misoprostol and placebo.
Causal relationship unknown
The following adverse events were infrequently reported. Causal relationships between misoprostol and these events have not been established but cannot be excluded:
Body as a whole: aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes.
Skin: rash, dermatitis, alopecia, pallor, breast pain.
Special senses: abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache.
Respiratory: upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis.
Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA).
Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase.
Hypersensitivity: anaphylactic reaction
Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase.
Genitourinary: polyuria, dysuria, hematuria, urinary tract infection.
Nervous system/Psychiatric: anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion.
Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain.
Blood/Coagulation: anemia, abnormal differential, thrombocytopenia, purpura, ESR increased.
OVERDOSAGE
The toxic dose of misoprostol in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy.
It is not known if misoprostol acid is dialyzable. However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.
DOSAGE & ADMINISTRATION
The recommended adult oral dose of misoprostol for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.
Renal impairment
Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)
HOW SUPPLIED
Round, white,scored,flat beveled-edged tablet, marked with ” N” above athe score-line and ” 444″ below score-line and plain on the reverse side,
NDC 681071-3458-4 BOTTLES OF 4
SPL PATIENT PACKAGE INSERT
PATIENT INFORMATION
Read this leaflet before taking misoprostol and each time your prescription is renewed, because the leaflet may be changed.
Misoprostol is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to the arthritis/pain medication that you take.
Do not take misoprostol to reduce the risk of NSAID-induced ulcers if you are pregnant. (See boxed WARNINGS.) Misoprostol can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprostol may cause the uterus to tear (uterine rupture) during pregnancy. The risk of uterine rupture increases as your pregnancy advances and if you have had surgery on the uterus, such as a Cesarean delivery. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.
If you become pregnant during misoprostol therapy, stop taking misoprostol and contact your physician immediately. Remember that even if you are on a means of birth control it is still possible to become pregnant. Should this occur, stop taking misoprostol and contact your physician immediately.
Misoprostol may cause diarrhea, abdominal cramping, and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week. You can minimize possible diarrhea by making sure you take misoprostol with food.
Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take misoprostol. If you have prolonged difficulty (more than 8 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.
Take misoprostol only according to the directions given by your physician.
Do not give misoprostol to anyone else. It has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant.
This information sheet does not cover all possible side effects of misoprostol. This patient information leaflet does not address the side effects of your arthritis/pain medication. See your doctor if you have questions.
Keep out of reach of children.
All trademarks are the property of their respective owners.
Distributed by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
Issued: 09/2022
LB4429-02
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| Labeler — NuCare Pharmaceuticals,Inc. (010632300) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| NuCare Pharmaceuticals,Inc. | 010632300 | repack (68071-3458) | |
Revised: 08/2023 NuCare Pharmaceuticals,Inc.
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